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| Name | Class |
|---|---|
| University of Ljubljana, Faculty of Medicine | OTHER |
| Medical University of Lublin | OTHER |
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Endometrial cancer (EC) is the most frequent gynecological malignancy but there is currently lack of both non-invasive diagnostic tools and novel markers to stratify patients based on their risk of future recurrence. Patient care could be improved by advances in these two aspects.
In the present study, the investigators aim to identify diagnostic serum metabolite and protein biomarker signatures for early detection of cancer in asymptomatic high-risk population and prognostic biomarkers for selection of patients with poor prognosis.
Rationale: Endometrial cancer (EC) is the most frequent gynaecological malignancy in the developed world. Optimal treatment of EC depends on early diagnostics and pre-operative stratification to appropriately select the extent of surgery and to plan further therapeutic approach. Currently, invasive endometrial histology is the gold standard for diagnosis, as there are no valid non-invasive methods available, and patient stratification is based on histopathology and surgical findings. There is a great need for efficient and reliable screening test for asymptomatic women with high risk of EC including Lynch syndrome patients and tamoxifen treated patients. In addition, a prognostic test is needed to stratify pre-operatively EC patients with high risk of progression in need of radical surgery together with adjuvant chemo/ratio therapy from EC patients with good prognosis. In this project the investigators are addressing this lack of non-invasive diagnostic and prognostic biomarkers of EC.
Objective: the investigators aim to identify diagnostic serum metabolite and protein biomarker signatures for early detection of cancer in asymptomatic high-risk population and (secondary objective) prognostic biomarkers for selection of patients with poor prognosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cases | Women older than 18 years and diagnosed with endometrial cancer will be included. Blood sampling will be performed on all subjects and will be used for proteomics and metabolomics analyses. |
| |
| controls | Women older than 18 years and with a benign endometrial disturbance will be included. Blood sampling will be performed on all subjects and will be used for proteomics and metabolomics analyses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sampling | Other | Blood sampling (10 mL) prior to standard care (e.g. surgery, medical treatment) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Creation of a diagnostic algorithm | Blood metabolome and proteome will be analysed and bioinformatics/biostatistical analysis will be used to derive diagnostic algorithms based on blood metabolites, proteins and clinical data. Algorithms in the biomarker discovery study will be developed by comparing EC and patients with benign uterine pathologies. | 2020-2021 |
| Measure | Description | Time Frame |
|---|---|---|
| Creation of a prognostic algorithm | Blood metabolome and proteome will be analysed and bioinformatics/biostatistical analysis will be used to derive prognostic algorithms based on blood metabolites, proteins, clinical data at baseline and follow up information. Algorithms in the biomarker discovery study will be developed by comparing EC patients with low risk and high risk for cancer progression and recurrence. |
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Inclusion Criteria Cases:
Inclusion Criteria Controls:
Exclusion Criteria Cases:
Exclusion Criteria Controls:
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Women older than 18 years and able to sign the informed consent.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Romano, Dr. | Contact | +31 433881286 | a.romano@maastrichtuniversity.nl | |
| Roy Kruitwagen, Prof. Dr. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Andrea Romano | Maastricht University Medical Centre | Principal Investigator |
| Tea Lanišnik Rižner, Prof. Dr. | Faculty of Medicine, University of Ljubljana, Slovenia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Centre | Recruiting | Maastricht | Netherlands |
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| Label | URL |
|---|---|
| Related Info | View source |
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To be discussed within the team, put planned
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| D004194 | Disease |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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serum samples
| 2021 |
| Maxima Medical Centre | Not yet recruiting | Veldhoven | Netherlands |
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| Lublin Medical University | Recruiting | Lublin | Poland |
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| Faculty of Medicine, University of Ljubljana | Not yet recruiting | Ljubljana | Slovenia |
|
| University Medical Centre, Ljubljana | Recruiting | Ljubljana | Slovenia |
|
| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |